18- 691 C.M.R. ch. 4, § 7

Current through 2024-51, December 18, 2024
Section 691-4-7 - Manufacturing Facility Organization
7.1 - Responsibilities of Management
A. A manufacturing facility must designate a manufacturing facility director who is responsible for ensuring the facility operates in compliance with this rule. If the manufacturing facility is owned by a qualifying patient or caregiver, the owner must be designated as the facility director.
B. A registered manufacturing facility with more than 5 assistants must identify a principal officer in addition to the facility director.
C. The management shall ensure that a person-in-charge, who can cooperate with any inspection, on-site assessment or complaint response, is present on the premises of any manufacturing facility during hours of operation or apparent activity.
D. A registrant, manufacturing facility director, principal officers and person-in -charge are responsible for the management of the manufacturing facility and supervision of its assistants.
E. Registry identification cards are required for all proprietors, partners, board members, facility directors, principal officers and assistants pursuant to 22 MRS, chapter 558-C. A registry identification card may not be issued to any person who has not attained 21 years of age.
F. A registered manufacturing facility must:
(1) Define the responsibilities of key personnel in the organization who have a management role; and
(2) Have policies and procedures to ensure the protection of its qualifying patients' confidential information, including procedures for protecting the electronic storage of confidential information.
G. A manufacturing facility with an inherently hazardous substances registration must define the responsibilities of key personnel in the organization who will be engaged in extraction using inherently hazardous substances.
7.2 -Director and Principal Officer Qualification Requirements
A. The facility director and, where applicable, principal officer(s) or person(s)-in-charge must have a high school qualifying degree, diploma or GED Equivalent.
B. The facility director and, where applicable, principal officer(s) or person(s)-in-charge may not have any conviction of a disqualifying drug offense.
7.3 - Personnel Documentation and Registrations A manufacturing facility must maintain the following records and present to the Department upon request:
A. Records of valid registry identification cards for each owner, partner, principal officer, board member and assistant, including the name of the cardholder, the date of issuance and expiration date of the identification card;
B. A copy of the criminal history record check, if a copy had been provided to the facility by the Department, and unique identification number for each of its owners, partners, principal officers, board members and assistants ;
C. Record of the qualifications of facility director and principal officer(s), or person(s)-in -charge, where applicable; and
D. Documentation of the responsibilities, training and supervision requirements of Sections 7.1 and 7.4.
7.4 - Personnel Training and Supervision The registered manufacturing facility director or principal officer must:
A. Provide adequate supervision of staff, including trainees, by persons familiar with standard operating procedures;
B. Ensure all staff has demonstrated capability in the activities for which they are responsible;
C. Formulate goals for education and training of the facility's personnel;
D. Have policies and procedures for identifying training needs and providing training of personnel; and
E.Ensure that the training of the registered manufacturing facility personnel is kept up to date (on-going) by providing the following:
(1) Training documentation on equipment, techniques, standard operating procedures and security protocols; and
(2) Training in ethical and legal responsibilities.

18- 691 C.M.R. ch. 4, § 7